scope:

This European Standard provides the procedure for the specific assessment required in EN 50527-1:2016, Annex A, for workers with implanted cardioverter defibrillators (ICDs) and Cardiac Resynchronization Therapy devices with associated defibrillation functions (CRT-D). Only devices of this type equipped with leads implanted transvenously are considered. It offers different approaches fordoing the risk assessment.

NOTE 1 If the worker has other Active Implantable Medical Devices (AIMDs) implanted additionally, they are assessed separately according to EN 50527-1 or other particular standards within the EN 50527 series.

NOTE 2 The risks to patients due to interference with pacing functions associated with CRT-D devices are assessed using EN 50527-2-1. The purpose of the specific assessment is to determine the risk for workers with implanted ICDs and CRT-Ds arising from exposure to electromagnetic fields (EMF) at the workplace. The assessment includes the likelihood of clinically significant effects and takes account of both transient and long-term exposure within specific areas of the workplace

NOTE 3 This standard does not address risks from contact currents.

The techniques described in the different approaches may also be used for the assessment of publicly accessible areas.

The frequency range to be observed is from 0 Hz to 3 GHz. Above 3 GHz no interference with the devices within the scope of this Particular Standard is expected to occur when the exposure limits are not exceeded.

NOTE 4The rationale for limiting the observation range to 3 GHz can be found in ISO 14117:2012, Clause 5.

NOTE 5Further information concerning the functions of Pacemakers, CRT-D, and ICD devices can be found in Ellen bogen and Kaszala, 2014. |